QUADRYDERN- hydrocortisone cream 
Productos Zapotol Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Quadrydern N.F. Hydrocortisone Cream 2oz (140, ZDP)

Active ingredient Purpose

Hydrocortisone 1%..................................................................Anti-itch

Uses

Warnings For external use only

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

Distributed By:

Productos Zapotol Corp.

Palmdale, CA 93550

Made in China

140

QUADRYDERN 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
WHITE WAX (UNII: 7G1J5DA97F)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59428-403-571 in 1 CARTON03/11/2020
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/11/2020
Labeler - Productos Zapotol Corp (186063850)

Revised: 3/2022
Document Id: db8b060c-4f61-7bc4-e053-2995a90aa789
Set id: a087ad4d-9a65-19c3-e053-2995a90ab341
Version: 2
Effective Time: 20220331
 
Productos Zapotol Corp